White Paper
New Era in Digital Compliance, Quality and Risk Management (CQRM)
The COVID-19 pandemic has expedited the requirement for digital transformation within the Life Sciences Industry, creating a new era in digital quality management. As new quality management processes are brought to life, leading life sciences companies are experiencing how digital transformation is an opportunity to overcome regulatory challenges and modernize their business processes. Life science leaders are leveraging a new generation of CQRM systems to supports the product life cycle from preclinical to launch and beyond.
The new era in quality, compliance, and risk management establishes the need for intelligent digital workplaces as an elaborate, unified ecosystem of product quality excellence. The latest innovative technologies of the digital CQRM system provide 21CFR part 11 compliance, e-audit, e-inspection, e-Sourcing, and e-reporting unified with the core process of R&D manufacturing, clinical operations, etc. Experts can now leverage the digital CQRM systems holistically and remotely on the cloud.
To be effective in the new era of electronic quality management, all companies need to:
- Re-imagine all processes for R&D, lab operating systems, and policies to enable continuous data integrity and enable a unified operational ecosystem.
- Create a new paradigm for the post-COVID-19 world of holistic digital quality management.
- Always be ready for e-Audit, e-Sourcing, and e-Inspections.
- Bring innovation to markets at rapid speeds with full regulatory compliance in the digital workplace.
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Gain holistic oversight of the entire product Lifecycle
Discover the new era in digital quality management
Achieve predictive Compliance, Quality, and Risk Management via AI and Machine Learning technologies
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A cloud based Compliance, Quality & Risk Management platform unified with R&D, Labs, Predictive Risk, Clinical, Manufacturing, and Document Management
- Over 40 Years of Quality and Compliance Expertise
- Awarded by FDA's NCTR for Data Management Software
- QMS Systems Custom Configured to Your Process - Your Way
- Patent Pending Predictive Risk Algorithms Provide Groundbreaking Quality Assurance Advancements
- Top 20 Pharmaceutical Companies use Xybion
